FDAClass IINovember 29, 2017

Surplug Micro Connector recall

SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32"…

Why was Surplug Micro Connector recalled?

ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 3458321, 3462452, 3465813, 3442569, 3446005, 3450752, 3465816, 3456237, 3486340, 3451451, 3447667, 3447427, 3471329, 3462010, 3447673, 3470589, 3466170, 3462856, 77-979-Y1, 76-113-Y1, 76-114-Y1, 77-981-Y1, 77-259-Y1, 77-023-HE, 77-481-Y1, 78-637-HE, 77-034-HE, 77-222-Y1, 77-341-HE, 77-354-Y1, 77-613-Y1, 77-033-HE, 76-101-Y1, 77-305-HE, 76-059-Y1, 77-149-Y1, 78-466-HE, 79-571-JW, 77-203-Y1

Product
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32"…
Recalling firm
ICU Medical, Inc.
Quantity
24,475 (17,225 in US)
Distribution
US Distribution and Internationally to TH.
Recall date
November 29, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls